FDA recall Z-3033-2026

IMRIS Imaging Inc · Class II · device

Product

ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000

Reason for recall

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.

Key facts

Status
Ongoing
Initiation date
2026-08-06
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3033-2026